Trial Review

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Non-invasive medical device for the treatment of chronic constipation: 1. Proof of Principle study in children.

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Scientific title

In children aged 4-18 years with chronic constipation, what is the effect of a new transcutaneous electrical stimulation device (rhythm.IC, GI Therapies) on defecation frequency and constipation symptoms?

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Secondary ID [1]2874000

nil

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Universal Trial Number (UTN)

U1111-1173-9182

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Trial acronym

rhythmIC PoP Child

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Chronic Constipation2961060

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Condition category

Condition code

Oral and Gastrointestinal29636229636200

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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

Transcutaneous Electrical Stimulation (TES) will be delivered from the rhythm.IC device, GI Therapies, Melbourne.electrical stimulation will be applied using sticky electrodes on the skin. Electrodes are applied for the period of stimulation only. There will be four electrodes applied on abdomen and another four on the lower back, held in place by a specially designed belt which also holds the small battery-powered stimulator used to control and deliver the current. The current is first applied at the lowest frequency and increased within the specified limits until tingling is felt and then raised until it becomes uncomfortable. The current intensity is then turned down to a comfortable level. This is set as the treatment level and is stored in the device memory. The device automatically ramps up to this level at a comfortable rate when turned on. . Stimulation will be applied at home for 60 min/day for 4 months. Current will be delivered via two channels, one at 4000 Hz and the other at 4080 to 4160 Hz to create a beat frequency of 80-160 Hz, Current will be delivered at the highest comfortable level for the patient (maximum intensity 40mA). The device records usage (time used in minutes and highest level used and date) and a report can be generated by the clinician showing a calendar with minutes used and highest level each day.

change in constipation symptom severity score (using the Wexner constipation scoring system. Constipation consists of a number of symptoms. The Wexner constipation scoring system measures 6 items using a value of 0 to 4 for each item (total score 24, higher score is worse constipation).

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Timepoint [1]2960110

at baseline and after 2 months stimulation.

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Secondary outcome [1]3194520

Defaecation frequency,- estimated by patient and recorded in daily stool diary

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Timepoint [1]3194520

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [2]3194530

Defaecation volume,- estimated by patient and recorded in daily stool diary

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Timepoint [2]3194530

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [3]3194540

Defaecation consistency - estimated by patient using the Bristol Stool Scale and recorded in daily stool diary

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Timepoint [3]3194540

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [4]3194550

Frequency of straining during defecation- estimated by patient and recorded in daily stool diary

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Timepoint [4]3194550

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [5]3194560

Feeling of incomplete evacuation- recorded in daily stool diary

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Timepoint [5]3194560

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [6]3194570

Abdominal pain- recorded in daily stool diary, using scale 0= never to 4 = always

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Timepoint [6]3194570

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [7]3194580

Bloating- recorded in daily stool diary using VAS scale 0 to 4, never to always

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Timepoint [7]3194580

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [8]3194590

Effect on daily activities. Patient/parent are asked if their constipation affects their daily activities. binary yes/no

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Timepoint [8]3194590

measured at baseline, after 2 and 4 months stimulation and after 3 months without stimulation

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Secondary outcome [9]3194600

Laxative use- recorded in daily stool diary

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Timepoint [9]3194600

measured daily using diary for 2 weeks at baseline, for 4 months stimulation and for 2 weeks after 3 months without stimulation

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Secondary outcome [10]3194610

Quality of life (QOL) - questionnaires from PedsQL suite (Core, gastrointestinal scores and family functioning)

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Timepoint [10]3194610

measured at baseline, after 2 and 4 months stimulation and after 3 months without stimulation

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Secondary outcome [11]3194620

Ease/difficulty of use of device and instructions. Patient/parent is asked about use of the device and instructions- is it easy or difficult.

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Timepoint [11]3194620

after 4 months stimulation

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Secondary outcome [12]3194630

change in constipation symptom severity score (Wexner constipation scoring system) at two further time points

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Timepoint [12]3194630

after 4 months stimulation and a further 3 months without stimulation.

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Eligibility

Key inclusion criteria

Patients aged between 4 and 18 with chronic functional idiopathic constipation as defined by a > 6 month history of:*Less than or equal to two “spontaneous complete bowel movement” (SCBM)/week for at least 6 months prior to recruitment and*At least 25% of the time suffer from at least one symptom of: lumpy/hard stools, sensation of incomplete evacuation, need to strain during defaecation, or sensation of anorectal obstruction/blockage.

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Minimum age

4Years

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Maximum age

18Years

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Gender

Both males and females

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Can healthy volunteers participate?

No

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Key exclusion criteria

*Constipation secondary to endocrine causes, metabolic causes or neurological conditions*Known or suspected organic disorders of the large bowel*Serious chronic medical condition*Surgical procedure on the large bowel or rectum*Pregnancy or planning to become pregnant*Insufficient comprehension of English requiring a translator*Implanted cardiac defibrillator or pacemaker

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Study design

Purpose of the study

Treatment

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Allocation to intervention

Non-randomised trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

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Masking / blinding

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Who is / are masked / blinded?

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Intervention assignment

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Other design features

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Phase

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Type of endpoint(s)

Efficacy

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Statistical methods / analysis

Phase II, Proof of principal study on small group.

descriptive statistics

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Recruitment

Recruitment status

Not yet recruiting

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Date of first participant enrolment

Anticipated

12/12/2016

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Actual

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Date of last participant enrolment

Anticipated

31/10/2018

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

10

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Accrual to date

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Final

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Recruitment in Australia

Recruitment state(s)

VIC

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Recruitment hospital [1]42980

The Royal Childrens Hospital - Parkville

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Recruitment postcode(s) [1]102350

3052 - Parkville

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Funding & Sponsors

Funding source category [1]2919660

Commercial sector/Industry

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Name [1]2919660

GI therapies Pty Ltd

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Address [1]2919660

Level 9, 278 Collins St,Melbourne, VictoriaAustralia3052

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Country [1]2919660

Australia

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Primary sponsor type

Commercial sector/Industry

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Name

GI therapies Pty Ltd

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Address

Level 9, 278 Collins St,Melbourne, VictoriaAustralia3052

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Country

Australia

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Secondary sponsor category [1]2906350

None

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Name [1]2906350

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Address [1]2906350

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Country [1]2906350

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Ethics approval

Ethics application status

Submitted, not yet approved

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Ethics committee name [1]2934630

Royal Childrens Hospital Human Research and Ethics Committee

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Ethics committee address [1]2934630

Royal Children's HospitalRoyal ParadeParkvilleVictoriaAustralia3052note no street number required-the hospital is a landmark in a small suburb.

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Ethics committee country [1]2934630

Australia

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Date submitted for ethics approval [1]2934630

07/09/2015

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Approval date [1]2934630

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Ethics approval number [1]2934630

HREC/15/RCHM/85

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Summary

Brief summary

This study aims to determine proof-of-principle if a new medical device (rhythm.IC, GI Therapies) is able to improve symptoms of chronic constipation in children. the device delivers painless electrical stimulation across the skin.

The new device has been designed using existing devices with additional safety features and better ease of use. The device has not yet been tested on patients.

The study does not aim to measure overall effectiveness, but to determine if the new device is able to improve symptoms of chronic constipation in some patients.

The primary objective is to determine if stimulation with rhythm.IC can improve constipation symptoms measured with a global measure (Wexner constipation scoring system) after 2 months stimulation.